Device: Boston Scientific VALITUDE™ CRT-P Model U128, RESONATE™ CRT-D Model G447, MOMENTUM™ CRT-D Model G124, G125, G126, G128, AUTOGEN™ CRT-D Models G172, G173, G175, G177, G179 VISIONIST™ CRT-P Models U225, U226, U228, DYNAGEN™ CRT-D Models G151, G156, G158
TGA Reference: RC-2017-RN-01510-1
Software upgrade info
ANZCDACC Advisory Notice 1 December 2017
Device: Information About Cybersecurity for AccentTM AnthemTM Accent MRITM AccentSTTM AllureTM and Assurity MRITM and Assurity MRITM devices
TGA Reference: RC-2017-RN-01403-1
If patient has more than one CIED, they may not be able to send data or unintentionally from the other
Medtronic MyCareLink Remote Monitors: Models 24950 and 25000
ANZCDACC Advisory Notice 29th November 2017
TGA Reference: RC-2017-RN-01009-1
Hardware component which can cause battery overconsumption at implant and MRI
ANZCDACC Advisory Notice 7th September 2017
Device: LivaNova (Formerly Sorin Group) Platinium™ ICDs and CRTDs
TGA Reference: RC-2017-RN-00913-1
Device: EMBLEM™ S-ICDs (Models A209 and A219) and SQ-RXTM S-ICDs (Model 1010)
ANZCDACC Advisory Notice 14th July 2017
TGA Ref: RC-2017-RN-00830-1
ANZCDACC Advisory Notice 24th May 2017
Device: LivaNova Ovatio, Paradym RF and Intensia ICD’s and CRT’s
ANZCDACC Advisory Notice 20th January 2017
Advisory Grade TGA: TBA (Hazard Alert (Recall for product correction))
ANZDACC Advisory Grade: Routine
Description: Potential RF interference during programmer interrogation of S-ICD with potential to cause temporary and/or permanent unintended programming changes. Latitude remote monitoring not affected.
Ten observations of unintended programming have been reported.
One inappropriate shock and therapy programmed off in another device. One device returned to nominal factory settings.
Risk: Overall risk of adverse event is calculated at 1/25,000 in 5 years for EMBLEM devices and 1/200,000 in 5 years for SQ-RX devices.
In Australia there are 385 devices affected and New Zealand 93 devices.
Presentation: Patients with inappropriate shocks, failure to deliver therapy due to unintended programming (therapies off), unexpected programming changes on home monitoring or at routine review.
Advice: A software update will be released at a future date to rectify this issue. Home monitoring is recommended and if a programmer needs to be used that the device should be reinterrogated immediately after ending session to ensure that there hasn’t been any unintended programming.
Use remote monitoring for routine follow up where ever possible. Reduce frequency of in clinic checks while following medical society guidelines.
Do not leave patient unattended in clinic while an active telemetry session is in progress. Ensure external defibrillation equipment and appropriately trained staff are readily available during in office follow up.
Minimize duration of programmer communication and end telemetry session promptly.
Contact Boston Scientific technical services for assistance should unintended programming occur.
Device: Medtronic Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ Cardiac Resynchronization Therapy Defibrillators (CRT-D) Models DTMB2D1 DTMB2D4 DTMB2QQ DTMA2D1 DTMA2Q1 DTMA2QQ DTMA2D4
ANZCDACC – Advisory Notice: 1 November 2016
Device: LivaNova Field Safety Notice Applicable to REPLY Models D, DR, VDR, SR ESPRIT Models D, DR, S, SR, FACIL Model DR pacemakers
ANZCDACC Advisory Notice 30 August 2016
Device: Medtronic Viva Cardiac Resynchronisation Therapy Defibrillators and Evera Implantable Cardioverter Defibrillators
Note: The advisory has only been issued for one particular batch of these generators consisting of 78 devices worldwide. No other Viva or Evera devices are affected.
